Kornimate/medical-research-clean huggingface dataset:
reduce crohn's-associated diarrhea with sodium channel therapy

Conditions: Crohn's Disease; Inflammatory Bowel Disease

Summary: crohn's disease is an inflammatory disorder that can affect any part of the gastrointestinal (gi) tract. some patients still experience persistent diarrhea or other symptoms such as abdominal pain even when their crohn's disease is in remission. diarrhea and/or abdominal pain that is not responsive to standard therapies can significantly affect a patient's quality of life and ability to work. the purpose of this study is to test the safety and effectiveness of the drug ranolazine in reducing crohn's disease-associated diarrhea and other symptoms. ranolazine is approved by the us food \& drug administration (fda) for chronic angina (a heart condition). this study is investigating if ranolazine could be used in the setting of crohn's disease.


Eligibility criteria:
inclusion criteria: * meet diagnostic criteria for crohn's disease with active diarrhea either with active disease or in remission (as defined by endoscopic or radiographic findings) but experiencing symptoms (e.g., diarrhea, abdominal pain) * have greater than three loose stools per day exclusion criteria: * male and female subjects \<18 years of age * significant change in medication including prednisone, antidepressant medications, or stimulants within the last 4 weeks a. allowances include: rectal hydrocortisone, rectal mesalamine, addition of prednisone (up to 20mg) for flares, etc. * regular (daily) use of opioids or other drugs of abuse including heavy alcohol or marijuana use * severe psychiatric disease including schizophrenia, psychosis, suicidal depression * previous use of ranolazine within 2 months prior to enrollment * prior use of ranolazine which was discontinued for safety or tolerability * metabolic derangement defined as liver function tests \>3x upper limit of normal or severe renal disease defined as calculated creatinine clearance \<30 ml/min * have liver cirrhosis * concurrent use of cyp3a inhibitors, inducers, or substrates a. these may include: ketoconazole, itraconazole, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir, clarithromycin, or rifampin, rifapentine, phenobarbital, phenytoin, and st. john's wort, digoxin. * a family history of (or congenital) long qt syndrome or known acquired qt interval prolongation * inability or refusal to give informed consent for any reason including a diagnosis of dementia or cognitive impairment * patients who are pregnant or breastfeeding * patients who are enrolled in other investigational drug studies or who have taken investigational drugs within 30 days before enrollment * other factors which in the opinion of the investigator could potentially impact the study outcomes (e.g., underlying disease, medications, history) or prevent the participant from completing the protocol (poor compliance or unpredictable schedule)

Keywords: diarrhea
neuromotor development and motor related health care in children with a high risk neonatal period

Conditions: Motor Disorders; Neurodevelopmental Disorders; Premature Birth; Hypoxic-Ischemic Encephalopathy; Small for Gestational Age At Delivery

Summary: the overall aim of the study is to evaluate the prevalence of motor- and neurological disorders (cerebral pares and other less severe motor disorders) in swedish infants with a high-risk neonatal period and to elucidate whether these children receive motor related health care (mrhc) at 2 and or 5,5 years of age.

specific aims: 1. to evaluate the prevalence of cerebral pares (cp) and other motor impairments in swedish infants with a high-risk neonatal period (total group and sub-groups), followed up at age 2 and or 5,5 years. 2. to study how retinopathy of prematurity (rop) affects the risk for later gross and fine motor impairments in children with a high-risk neonatal period, with specific reference to children born extremely preterm. 3. to study the number of children, with a high-risk neonatal period having access to mrhc (defined as having at least one visit over the previous year to a physiotherapist and/or an occupational therapist). * to evaluate possible associations between receiving mrhc and maternal-, pregnancy- and neonatal factors. * to study the association between receiving mrhc and cognition, motor function, behavior, quality of life and autism spectrum disorders (asd) at age 2 and 5,5 years. 4. to study if there are regional differences in sweden in follow-up of cp and less severe motor disorders at the age of 2 and 5,5 years. 5. to assess the completeness and agreement of some developmental and motor disorders, neurosensory impairments and chronical diseases in the swedish neonatal quality register (snq) with the swedish national patient register (npr) and the cerebral palsy follow-up program (cpup).

Eligibility criteria:
inclusion criteria: * included in the snq registry and having a follow-up protocol for 2 and/or 5 years of age. exclusion criteria: * none if the above inclusion criteria ar true.

Keywords: brain hie sga preterm neurodevelopment motor related healthcare children motor function
neolexon® aphasia-app in acute aphasia after stroke

Conditions: Aphasia, Acquired; Stroke, Acute

Summary: up to now there is proven evidence of traditional logopedic therapy in aphasia, but recent computer-based algorithms also showed their evidence so far. due to small and heterogenous study populations further trials are urgently needed. this prospective, randomized, clinical \& experimental controlled noninvasive study is intended to provide data for the therapy of an individual approach in aphasia patients.

the prospective, randomized, clinical \& experimental controlled noninvasive study (lexi) is intended to start in 10/2019. adult and german speaking patients suffering from aphasia after stroke who give informed consent and whose life expectancy is estimated above 1 year are included and will be followed up for 3 months. if informed consent is not available their legal guardian will have to provide written informed consent for their contribution. after randomization participants are divided into two different groups: patients receiving a standard logopedic speech treatment versus individuals working with a computer-based solution (neolexon® app on mobile devices). both groups will also have self-training and therefore frequency and intensity of this is also going to be analyzed as well as in the clinical surrounding. there will be three different major ward rounds in both groups during the trial period where scales scoring the severity of aphasia are collected and compared (i.e. aabt or last). furthermore epidemiologic data and stroke scales (i.e. nihss, mrs) are evaluated. the last round will be the follow-up after 3 months. lexi will provide new data to fill the gap of organizational barriers and structural problems. our aim is to show modern alternative therapy algorithms that approach the individual problem to offer a potential tailored solution to patients.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * acute aphasia after stroke (ischemic oder hemorrhagic) * life expectancy ≥ 1 year * informed consent (presumed) * mother tongue: german exclusion criteria: * age \< 18 years * missing aphasia * life expectancy \< 1 year * mother tongue: other then german

Keywords: stroke aphasia speech therapy computer based
tailoring online continence promotion

Conditions: Urinary Incontinence in Old Age; Fecal Incontinence in Old Age

Summary: this project seeks to understand whether, and how, tailoring an online continence intervention can increase engagement and uptake of health behaviors known to improve bladder and bowel symptoms.

the investigators will conduct a two-arm, parallel, randomized, controlled trial (rct) comparing an online continence promotion program with standard weekly reminders (control arm) to an online continence promotion program with tailoring (treatment arm) to determine the impact of tailoring on program engagement. women in the treatment arm will receive tailored content and digital reminders for 24 weeks based on their individual characteristics, symptoms, and behaviors assessed at baseline, with reassessment of key inputs every 2 weeks resulting in re-tailored outputs. participants will complete electronic surveys at enrollment, 4, 12, and 24 weeks. to contextualize the findings from all 3 aims, a subset of participants will be invited to complete semi-structured qualitative interviews about their engagement with the program, their adoption of health behaviors, and their perceived barriers to and facilitators of engagement and behavior change.

Eligibility criteria:
inclusion criteria: * female * 50 years or older * can read \& write english * can use email * has access to an internet-connected device to use the online program exclusion criteria: * dementia * neurologic or musculoskeletal conditions in which pelvic floor muscle exercises are contraindicated * hematuria or bloody stools within last 6 months that has not been evaluated by a medical professional
prophylactic lidocaine spray for pain alleviation in women undergoing osmotic dilator insertion for second trimester dilatation and evacuation

Conditions: Pain Alleviation; Dilatation and Evacuation; Laminaria Placement

Summary: to examine whether application of lidocaine spray in cervical preparation for second trimester dilatation and evacuation alleviates pain and is superior to current protocol of preparation without analgesia and superior to placebo. a double- blind, randomized, placebo- controlled trial, performed at a single tertiary medical center. eligible participants aged 18 and older and about to undergo dilation \& evacuation of the uterus between 12 to 24 weeks of gestation. participants will be randomized using computer generated allocation to receive 10% xylocaine (lidocaine group) spray or normal saline 0.9% (placebo group), applied identically topically to the endocervix and ectocervix before laminaria insertion. the primary outcome will be the participant's reported pain score immediately after the first laminaria was inserted as measured on a 10 cm visual analog scale (vas). secondary outcomes wiil be reported pain scores at speculum removal, 15 minutes after speculum insertion and immediately before the d\&e procedure.


Eligibility criteria:
inclusion criteria: * • informed consent * women with a gestational age of 12-24 weeks by last menstrual period. exclusion criteria: * • crl assesed by ultrasound as \<10 weeks * clinical uterine size \>24 weeks * fetus bi parietal diameter \> 50 mm * known amide allergy

Keywords: lidocaine laminaria dilatation and evacuation pain
lacrimal deroofing for epiphora

Conditions: Lacrimal Stenosis of Both Eyes

Summary: puncto-canalicular abnormalities, such as obstruction and canaliculitis, are a significant cause of epiphora. they involve proximal lacrimal drainage system. proximal lacrimal obstructions classified into punctal stenosis canalicular obstructions. the basic principles in the treatment of punctal stenosis include creating an adequate opening, while maintaining the position of the punctum against the lacrimal lake, and preserving the lacrimal pump function. the severity of epiphora can be valued trough a grading system such as the munk scale, fluorescein dye disappearance test, and syringing and probing and contrast dacryocystography. canaliculitis is defined as infection of the proximal part of the lacrimal drainage system. this condition can be caused by primary infectious organisms or secondary to punctal plugs and lacrimal stents. diagnosing canaliculitis is frequently misdiagnosed. the management includes conservative measures, local massage, syringing, and irrigation. nevertheless, refractory cases required surgical intervention.

purpose: to report outcomes of proximal lacrimal deroofing in the management of proximal lacrimal drainage system abnormalities. inclusion criteria: at least 18 years old patients with lacrimal punctum stenosis and/or canaliculitis. exclusion criteria: trauma, thyroid eye disease, lacrimation and other causes of epiphora. evaluation: all patients underwent a comprehensive ophthalmic examination, and lacrimal drainage evaluation at baseline,2 weeks and 6 months after the surgery. outcome measures: munk scale for epiphora grading (0-5); 0 no epiphora ,1 epiphora requiring dabbing less than twice a day, 2 epiphora requiring dabbing 2-4 times a day, 3 epiphora requiring dabbing 5-10 times a day, 4 epiphora requiring dabbing more than 10 times a day, 5 constant epiphora. grading of external lacrimal puncum (0-5); score 0: no papilla and punctum (punctal atresia); surgery to create a papilla, score1: papilla is covered by a membrane; a #25 needle, followed by a punctal finder. exudative or true membrane or fibrosis, difficult to recognize with standard punctum dilator, score 2: less than normal size, but recognizable; a punctal finder and, then a standard punctum dilator required, score 3: normal; regular punctum dilator required, score 4: small slit (\< 2 mm); no intervention required, score 5 large slit (≥ 2 mm); no intervention required.

Eligibility criteria:
inclusion criteria: * epiphora due to lacrimal punctum stenosis and/or canaliculitis. exclusion criteria: • trauma, thyroid eye disease, lacrimation and other causes of epiphora.

Keywords: lacrimal
heart rate variability in pneumothorax

Conditions: Pneumothorax

Summary: changes in heart rate variability in anesthetized, ventilated patients undergoing tension pneumothorax for thoracoscopic cervical sympathectomy


Eligibility criteria:
inclusion criteria: * age 15 - 50 years * body mass index 25 - 45 exclusion criteria: * heart rate other than sinus * cardiac pacemaker status * heart transplant
the effect of high frequency oscillation on biological markers of lung injury

Conditions: Acute Respiratory Distress Syndrome

Summary: although mechanical ventilation is life saving, it is associated with a number of severe complications collectively referred to as ventilator induced lung injury (vili). vili contributes to the high morbidity and mortality associated with the acute respiratory distress syndrome (ards). within the context of a randomized study evaluating the feasibility of conducting a study comparing high frequency oscillation to conventional lung protective ventilation in early severe ards, we are evaluating the effect of both ventilator strategies on biological markers of vili.

specific objectives: to measure known biomarkers conventionally associated with vili and biotrauma to measure potential novel biomarkers of vili and biotrauma to identify the best time point for biomarker measurement to collect and store samples for differential expression and genomic analysis

Eligibility criteria:
inclusion criteria: informed consent previously obtained for enrollment in the oscillate study: 1. acute onset of respiratory failure 2. endotracheal intubation or tracheostomy 3. hypoxemia (p:f \<200 mmhg) 4. bilateral alveolar consolidation exclusion criteria: 1. refusal of consent to participate in this biomarkers substudy

Keywords: acute respiratory distress syndrome ventilator induced lung injury high frequency oscillation lung protective ventilation biomarkers biotrauma
an investigational scan (mr dense) in detecting early chemotherapy-related liver injury before surgery in patients with resectable colorectal liver metastases

Conditions: Colorectal Carcinoma Metastatic in the Liver

Summary: this trial studies how well a magnetic resonance imaging technique called displacement encoding with stimulated echo (dense) works in detecting chemotherapy-related liver injury in patients with colorectal cancer that has spread to the liver and can be removed by surgery. researchers want to learn if the dense technique improves the standard mri method.

primary objective: i. this is an exploratory study to collect magnetic resonance displacement encoding with stimulated echo (mr dense) imaging data of patients treated with chemotherapy prior to resection of metastases to explore its utility in detecting sinusoidal liver injury. secondary objectives: i. estimate sensitivity of mr dense (determine degree of 2 dimensional \[2d\] vector displacement with cardiac cycle and variability of measurements with cardiac ventricle contraction). ii. determine detection of sinusoidal injury (sinusoidal fibrosis, necrosis of pericentral hepatocytes, narrowing and fibrosis of central veins) on biopsy with non-alignment of 2d point vectors (horizontal and vertical direction) from neighboring/immediate adjacent points on mr dense imaging. iii. determine correlation of intra-operative surgical scores (liver color and texture) with non-alignment of 2d point vectors (horizontal and vertical direction) from neighboring/immediate adjacent points on mr dense imaging. outline: patients undergo standard of care magnetic resonance imaging (mri) and then undergo an mri of the liver using mr dense imaging sequences over 60-90 minutes. healthy volunteers undergo mri of the liver using dense imaging sequences.

Eligibility criteria:
inclusion criteria: * patients treated with neoadjuvant chemotherapy and scheduled for hepatectomy, per standard of care at our institution, and meet criteria for hepatectomy. * no contraindications to mri (such implanted ferromagnetic or pump devices, metallic fragments in eye), as indicated on our departmental mri screening form. * patient who is able to undergo informed consent. * men and non-pregnant women. * metastatic disease limited to liver. * metastases involving no more than 6 liver segments. * no radiographic evidence of involvement of the hepatic artery, major bile ducts, main portal vein, celiac/para aortic lymph nodes. exclusion criteria: * contraindication to mri. * inability to comply with study and/or follow-up procedures. * unable to provide informed consent. * presence of extrahepatic metastatic disease. * metastases involving more than 6 liver segments. * radiographic evidence of involvement of the hepatic artery, major bile ducts, main portal vein, celiac/para aortic lymph nodes. * pregnant women.
spermotrend in the treatment of male infertility

Conditions: Male Infertility

Summary: the purpose of this study is to determine whether the administration of the dietary supplement spermotrend improves spermatogenesis parameters in subjects with male infertility unrelated to major testicular conditions. the duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. the estimated number of males with infertility to be recruited and randomized for the study is 86.


Eligibility criteria:
inclusion criteria: * male infertility unrelated to major testicular conditions * must have at least one altered seminal parameter. * signed informed consent exclusion criteria: * hydrocele, varicocele, orchitis, epididymitis, irradiation or chemotherapy. * previously treated and cured testicular condition. * non-transmissible chronic diseases * use of antioxidant agents within 6 months. * use of vitamins within 6 months. * use of anti-inflammatory drugs within 6 months. * use of hormones prescribed by an andrologist within 6 months * positive serology/hiv * leukocytospermia

Keywords: dietary supplement male infertility spermatogenesis
orthopulse 2.0 and 2.1 feasibility evaluation

Conditions: Malocclusion

Summary: orthopulse is a device that uses near-infrared light therapy in order to decrease orthodontic treatment time. the aim of this study is to evaluate orthopulse products modified with extended arrays, orthopulse 2.0 and orthopulse 2.1, and to assess their clinical effectiveness.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any assessment is performed * patient must be 11 years of age or older; minors will only be included in the study with the consent of the parent/legal authorized representative (lar) * presence of permanent dentition * eligible and scheduled for full mouth fixed orthodontic treatment or invisalign * good oral hygiene * likely to be compliant to orthopulse 2.0 and 2.1 use, aligner wear and elastic wear * have a compatible ios or android device and are willing to download the orthopulse app for frequent automatic syncing of use data exclusion criteria: * patient is currently enrolled in another clinical study * periodontally involved teeth, acute oral infection or periodontal disease * use of bisphosphonates (osteoporosis drugs) during the study * use of drugs that may cause photosensitivity * history of photosensitivity * history of poor oral hygiene, per the discretion of the principal investigator (pi) * epilepsy * patient plans to relocate over the treatment period * smoker or use of any tobacco containing products per the discretion of the pi

Keywords: malocclusion photobiomodulation biolux orthopulse low-level laser therapy orthodontics
efficacy of an arabic articulatory error remediation software program in patients with velopharyngeal valve dysfunction:

Conditions: Velopharyngeal Insufficiency; Articulation Disorders; Hypernasality Syndrome Due to Velopharyngeal Weakness

Summary: to develop a remediation software program that is specific for correcting speech errors in patients with velopharyngeal dysfunction in the arabic language and test its efficacy, on one group comparing pre and post results

the study was carried on 40 patients having articulation errors in cases of velopharyngeal valve dysfunction attending the unit of phoniatrics, otorhinolaryngology department, alexandria university. the patients met the specified inclusion and exclusion criteria. the patient underwent pre intervention evaluation and 3 parameters were chosen to compare efficacy of the program before and after therapy. these include auditory perceptual assessment of speech, nasometer test and articulation test. the patient underwent the remediation software program as individual sessions. then after finishing the therapy, the patients underwent post therapeutic evaluation with the 3 specified criteria statistical analysis was carried out using spss statistics software version 23. quantitative data were tested for normality using the kolmogorov-smirnov test. the variables which were normally distributed were described by mean± sd. the variables which were not normally distributed, were described by median (min-max). qualitative data were expressed by numbers and percentages. the results were calculated at a level of significance of 5% or less.

Eligibility criteria:
inclusion criteria: * clinically presented by articulation errors due to velopharyngeal dysfunction * age of 5 years and above with * must have normal hearing and vision. exclusion criteria: * unrepaired cleft palate. * large palatal fistula. * brain damage and intellectual disability.

Keywords: velopharyngeal dysfunction hypernasality